← FDA Drug Approvals (Drugs@FDA)
EZETIMIBE AND SIMVASTATIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2017-12-22
Drug application
- FDA Application #
ANDA209222- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EZETIMIBE AND SIMVASTATIN
- Generic name
- EZETIMIBE AND SIMVASTATIN
- Active ingredients
- EZETIMIBE; SIMVASTATIN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2017-12-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown